8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
THE ABBOTT EXECUTIVE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Cannulated Hemi Implant
FDA 510(k)
FDA Class 2
·Orthopedic
BROMCRESOL GREEN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
M2A-TAPER LINER SZ 41/32
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWY·May 5, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 15, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 16, 2007
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024